Vetoquinol USA Issues Recall for Cattle Fertility Drug Due to Particulate Matter

Vetoquinol USA, Inc. is voluntarily recalling six specific lots of its FOLLTROPIN® Injectable Kits for cattle due to the presence of particulate matter discovered in the sterile diluent vials. The recall, announced by the U.S. Food and Drug Administration, impacts a product used to induce superovulation in beef and dairy cattle.

The presence of foreign material in injectable products can pose a health risk to animals. Vetoquinol USA has identified that the administration of an injectable product containing particulate matter could lead to adverse reactions at the injection site or a hypersensitivity reaction. Potential clinical signs in affected animals may include pain, swelling at the injection site, decreased activity, fever, or labored breathing. Cattle producers who administer the affected product and observe any concerning symptoms in their animals are advised to seek veterinary attention promptly. While Vetoquinol USA has not reported any adverse events associated with these specific lots, the company is taking proactive measures to address the issue.

The recalled FOLLTROPIN Injectable Kits are identified by specific lot numbers for the diluent vials. These include diluent lot numbers 840915, 844585, 844583, 934975, 934976, and 934973. The corresponding kit lot numbers are 510578, 510579, 510580, 510581, 717059, and 510582. These kits contain a lyophilized follicle-stimulating hormone (FSH) powder and a sterile bacteriostatic saline diluent. The recall specifically pertains to the diluent component, as Vetoquinol USA has reported no issues with the FOLLTROPIN powder vials. FOLLTROPIN is also sold in a Dual Pack format, which does not contain diluent vials and is therefore not included in this recall.

The particulate matter was identified during a routine annual examination of retained samples of the sterile diluent vials. The affected product was distributed nationwide by veterinary distributors in the U.S.

Animal owners who are in possession of FOLLTROPIN Kits from the recalled lots are instructed to cease using the product immediately and to quarantine the affected items. Vetoquinol USA is providing further guidance on the return or disposal of the recalled product. For additional information or to arrange for the return of affected product, customers can contact Vetoquinol USA, Inc. at 1-800-267-5707, Monday through Friday, between 8 a.m. and 5 p.m. Central Standard Time.

Quality issues or adverse reactions experienced with any animal health product can be reported to the FDA by calling 1-888-FDA-VETS or through the FDA’s online reporting portal at http://www.fda.gov/reportanimalae. This company announcement is being made with the acknowledgment of the Food and Drug Administration.

Article by Mel Anara, based upon information from Vetoquinol USA, Inc. and the U.S. Food and Drug Administration.

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